Upper and/or lower gastrointestinal adverse events with glucagon‐like peptide‐1 receptor agonists: Incidence and consequences
Aims To characterize gastrointestinal adverse events (AEs) with different glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs). Methods Two retrospective intention‐to‐treat analyses of 6‐month patient‐level data were conducted. Data from three studies comparing exenatide once weekly (n = 617) with e...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2017-05, Vol.19 (5), p.672-681 |
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| creator | Horowitz, Michael Aroda, Vanita R. Han, Jenny Hardy, Elise Rayner, Chris K. |
| description | Aims
To characterize gastrointestinal adverse events (AEs) with different glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs).
Methods
Two retrospective intention‐to‐treat analyses of 6‐month patient‐level data were conducted. Data from three studies comparing exenatide once weekly (n = 617) with exenatide twice daily (n = 606) were pooled, and one (DURATION‐6) comparing exenatide once weekly (n = 461) with liraglutide (n = 450) was analysed separately. Patient‐reported gastrointestinal AEs were classified as upper or lower, AE incidences and timing were determined, subgroups were analysed, and associations of gastrointestinal AEs with efficacy were examined.
Results
Nausea was the most common gastrointestinal AE for all treatments. Fewer exenatide once‐weekly‐treated vs exenatide twice‐daily‐ or liraglutide‐treated patients reported gastrointestinal AEs (34% vs 45% and 25% vs 41%, respectively; both
P
|
| doi_str_mv | 10.1111/dom.12872 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5412849</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1891883119</sourcerecordid><originalsourceid>FETCH-LOGICAL-p4302-e3c9671ca37bddb6e96d86a6d891ad474e86c31b77c110a41d53a440e4715eff3</originalsourceid><addsrcrecordid>eNp9UstuFDEQHCEQCYEDP4AsceEyWffY4_FwQIrCK1JQLuRsee3ejYPXHuyZXeUGf8A38iV4NiECDvhgd6lK5XK7q-o50GMoa2Hj5hga2TUPqkPggtXAGvFwXze17GlzUD3J-ZpSypnsHlcHjaSt7ER_WH2_HAZMRAe7iIn4uCtgrfOYogsj5tEF7Ym2W0wZCW4xjJns3HhF1n4yeh3Dz28_vPuCZMBhdBYLBJLQFFT8ZoHLY35NzoIpbDA4X0VMDBm_TjPOT6tHK-0zPrs7j6rL9-8-n36szy8-nJ2enNcDZ7SpkZledGA065bWLgX2wkqhy9aDtrzjKIVhsOw6A0A1B9syzTlF3kGLqxU7qt7c-g7TcoPWlKck7dWQ3EanGxW1U38zwV2pddyqlpfe8r4YvLozSLFkz6PauGzQex0wTllBSSIlA5ilL_-RXscplVZmxWjb84a1kv5PVYz6hgpgUFQv_sx9H_j3HxbB4lawcx5v7nmgah4OVYZD7YdDvb34tC_YLwn5sE4</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1889206131</pqid></control><display><type>article</type><title>Upper and/or lower gastrointestinal adverse events with glucagon‐like peptide‐1 receptor agonists: Incidence and consequences</title><source>MEDLINE</source><source>Wiley Online Library</source><creator>Horowitz, Michael ; Aroda, Vanita R. ; Han, Jenny ; Hardy, Elise ; Rayner, Chris K.</creator><creatorcontrib>Horowitz, Michael ; Aroda, Vanita R. ; Han, Jenny ; Hardy, Elise ; Rayner, Chris K.</creatorcontrib><description>Aims
To characterize gastrointestinal adverse events (AEs) with different glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs).
Methods
Two retrospective intention‐to‐treat analyses of 6‐month patient‐level data were conducted. Data from three studies comparing exenatide once weekly (n = 617) with exenatide twice daily (n = 606) were pooled, and one (DURATION‐6) comparing exenatide once weekly (n = 461) with liraglutide (n = 450) was analysed separately. Patient‐reported gastrointestinal AEs were classified as upper or lower, AE incidences and timing were determined, subgroups were analysed, and associations of gastrointestinal AEs with efficacy were examined.
Results
Nausea was the most common gastrointestinal AE for all treatments. Fewer exenatide once‐weekly‐treated vs exenatide twice‐daily‐ or liraglutide‐treated patients reported gastrointestinal AEs (34% vs 45% and 25% vs 41%, respectively; both
P
< .0001). Fewer exenatide once‐weekly‐treated patients reported upper plus lower events than liraglutide‐treated patients (
P
< .001); the difference between exenatide once weekly and twice daily was not significant. Within each group, more women than men reported gastrointestinal AEs. Events occurrred early and were predominantly mild. Glycated haemoglobin reductions were similar for patients with or without gastrointestinal AEs. Weight loss was greater for patients with gastrointestinal AEs with exenatide once weekly and exenatide twice daily (
P
< .05); no difference was observed in DURATION‐6.
Conclusions
Gastrointestinal AEs were less frequent with exenatide once weekly vs exenatide twice daily or liraglutide, and combined upper and lower events occurred less often. Gastrointestinal AEs were typically mild and occurred early. Gastrointestinal AEs did not affect glycaemic control but may be associated with greater weight loss.</description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.12872</identifier><identifier>PMID: 28058769</identifier><identifier>CODEN: DOMEF6</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject><![CDATA[Adverse events ; Agonists ; Antidiabetics ; Diabetes ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - drug therapy ; Drug Administration Schedule ; Exenatide ; Female ; Gastrointestinal Diseases - chemically induced ; Gastrointestinal Diseases - epidemiology ; Gastrointestinal Diseases - physiopathology ; gastrointestinal disorders ; GLP-1 receptor agonists ; Glucagon ; Glucagon-Like Peptide-1 Receptor - agonists ; Glucagon-Like Peptide-1 Receptor - metabolism ; Glycated Hemoglobin A - analysis ; Hemoglobin ; Humans ; Hyperglycemia - prevention & control ; Hypoglycemia - prevention & control ; Incidence ; Incretins - administration & dosage ; Incretins - adverse effects ; Incretins - therapeutic use ; Intention to Treat Analysis ; liraglutide ; Liraglutide - administration & dosage ; Liraglutide - adverse effects ; Liraglutide - therapeutic use ; Male ; Nausea - chemically induced ; Nausea - epidemiology ; Nausea - physiopathology ; Original ; Patient Dropouts ; Patients ; Peptides ; Peptides - administration & dosage ; Peptides - adverse effects ; Peptides - therapeutic use ; Retrospective Studies ; Self Report ; Severity of Illness Index ; Sex Factors ; type 2 diabetes ; Venoms - administration & dosage ; Venoms - adverse effects ; Venoms - therapeutic use ; Weight Loss - drug effects]]></subject><ispartof>Diabetes, obesity & metabolism, 2017-05, Vol.19 (5), p.672-681</ispartof><rights>2017 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.</rights><rights>2017 John Wiley & Sons Ltd</rights><rights>2017. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0002-5527-256X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdom.12872$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.12872$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28058769$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Horowitz, Michael</creatorcontrib><creatorcontrib>Aroda, Vanita R.</creatorcontrib><creatorcontrib>Han, Jenny</creatorcontrib><creatorcontrib>Hardy, Elise</creatorcontrib><creatorcontrib>Rayner, Chris K.</creatorcontrib><title>Upper and/or lower gastrointestinal adverse events with glucagon‐like peptide‐1 receptor agonists: Incidence and consequences</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>Aims
To characterize gastrointestinal adverse events (AEs) with different glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs).
Methods
Two retrospective intention‐to‐treat analyses of 6‐month patient‐level data were conducted. Data from three studies comparing exenatide once weekly (n = 617) with exenatide twice daily (n = 606) were pooled, and one (DURATION‐6) comparing exenatide once weekly (n = 461) with liraglutide (n = 450) was analysed separately. Patient‐reported gastrointestinal AEs were classified as upper or lower, AE incidences and timing were determined, subgroups were analysed, and associations of gastrointestinal AEs with efficacy were examined.
Results
Nausea was the most common gastrointestinal AE for all treatments. Fewer exenatide once‐weekly‐treated vs exenatide twice‐daily‐ or liraglutide‐treated patients reported gastrointestinal AEs (34% vs 45% and 25% vs 41%, respectively; both
P
< .0001). Fewer exenatide once‐weekly‐treated patients reported upper plus lower events than liraglutide‐treated patients (
P
< .001); the difference between exenatide once weekly and twice daily was not significant. Within each group, more women than men reported gastrointestinal AEs. Events occurrred early and were predominantly mild. Glycated haemoglobin reductions were similar for patients with or without gastrointestinal AEs. Weight loss was greater for patients with gastrointestinal AEs with exenatide once weekly and exenatide twice daily (
P
< .05); no difference was observed in DURATION‐6.
Conclusions
Gastrointestinal AEs were less frequent with exenatide once weekly vs exenatide twice daily or liraglutide, and combined upper and lower events occurred less often. Gastrointestinal AEs were typically mild and occurred early. Gastrointestinal AEs did not affect glycaemic control but may be associated with greater weight loss.</description><subject>Adverse events</subject><subject>Agonists</subject><subject>Antidiabetics</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Drug Administration Schedule</subject><subject>Exenatide</subject><subject>Female</subject><subject>Gastrointestinal Diseases - chemically induced</subject><subject>Gastrointestinal Diseases - epidemiology</subject><subject>Gastrointestinal Diseases - physiopathology</subject><subject>gastrointestinal disorders</subject><subject>GLP-1 receptor agonists</subject><subject>Glucagon</subject><subject>Glucagon-Like Peptide-1 Receptor - agonists</subject><subject>Glucagon-Like Peptide-1 Receptor - metabolism</subject><subject>Glycated Hemoglobin A - analysis</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Hyperglycemia - prevention & control</subject><subject>Hypoglycemia - prevention & control</subject><subject>Incidence</subject><subject>Incretins - administration & dosage</subject><subject>Incretins - adverse effects</subject><subject>Incretins - therapeutic use</subject><subject>Intention to Treat Analysis</subject><subject>liraglutide</subject><subject>Liraglutide - administration & dosage</subject><subject>Liraglutide - adverse effects</subject><subject>Liraglutide - therapeutic use</subject><subject>Male</subject><subject>Nausea - chemically induced</subject><subject>Nausea - epidemiology</subject><subject>Nausea - physiopathology</subject><subject>Original</subject><subject>Patient Dropouts</subject><subject>Patients</subject><subject>Peptides</subject><subject>Peptides - administration & dosage</subject><subject>Peptides - adverse effects</subject><subject>Peptides - therapeutic use</subject><subject>Retrospective Studies</subject><subject>Self Report</subject><subject>Severity of Illness Index</subject><subject>Sex Factors</subject><subject>type 2 diabetes</subject><subject>Venoms - administration & dosage</subject><subject>Venoms - adverse effects</subject><subject>Venoms - therapeutic use</subject><subject>Weight Loss - drug effects</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp9UstuFDEQHCEQCYEDP4AsceEyWffY4_FwQIrCK1JQLuRsee3ejYPXHuyZXeUGf8A38iV4NiECDvhgd6lK5XK7q-o50GMoa2Hj5hga2TUPqkPggtXAGvFwXze17GlzUD3J-ZpSypnsHlcHjaSt7ER_WH2_HAZMRAe7iIn4uCtgrfOYogsj5tEF7Ym2W0wZCW4xjJns3HhF1n4yeh3Dz28_vPuCZMBhdBYLBJLQFFT8ZoHLY35NzoIpbDA4X0VMDBm_TjPOT6tHK-0zPrs7j6rL9-8-n36szy8-nJ2enNcDZ7SpkZledGA065bWLgX2wkqhy9aDtrzjKIVhsOw6A0A1B9syzTlF3kGLqxU7qt7c-g7TcoPWlKck7dWQ3EanGxW1U38zwV2pddyqlpfe8r4YvLozSLFkz6PauGzQex0wTllBSSIlA5ilL_-RXscplVZmxWjb84a1kv5PVYz6hgpgUFQv_sx9H_j3HxbB4lawcx5v7nmgah4OVYZD7YdDvb34tC_YLwn5sE4</recordid><startdate>201705</startdate><enddate>201705</enddate><creator>Horowitz, Michael</creator><creator>Aroda, Vanita R.</creator><creator>Han, Jenny</creator><creator>Hardy, Elise</creator><creator>Rayner, Chris K.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-5527-256X</orcidid></search><sort><creationdate>201705</creationdate><title>Upper and/or lower gastrointestinal adverse events with glucagon‐like peptide‐1 receptor agonists: Incidence and consequences</title><author>Horowitz, Michael ; Aroda, Vanita R. ; Han, Jenny ; Hardy, Elise ; Rayner, Chris K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p4302-e3c9671ca37bddb6e96d86a6d891ad474e86c31b77c110a41d53a440e4715eff3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adverse events</topic><topic>Agonists</topic><topic>Antidiabetics</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Drug Administration Schedule</topic><topic>Exenatide</topic><topic>Female</topic><topic>Gastrointestinal Diseases - chemically induced</topic><topic>Gastrointestinal Diseases - epidemiology</topic><topic>Gastrointestinal Diseases - physiopathology</topic><topic>gastrointestinal disorders</topic><topic>GLP-1 receptor agonists</topic><topic>Glucagon</topic><topic>Glucagon-Like Peptide-1 Receptor - agonists</topic><topic>Glucagon-Like Peptide-1 Receptor - metabolism</topic><topic>Glycated Hemoglobin A - analysis</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hyperglycemia - prevention & control</topic><topic>Hypoglycemia - prevention & control</topic><topic>Incidence</topic><topic>Incretins - administration & dosage</topic><topic>Incretins - adverse effects</topic><topic>Incretins - therapeutic use</topic><topic>Intention to Treat Analysis</topic><topic>liraglutide</topic><topic>Liraglutide - administration & dosage</topic><topic>Liraglutide - adverse effects</topic><topic>Liraglutide - therapeutic use</topic><topic>Male</topic><topic>Nausea - chemically induced</topic><topic>Nausea - epidemiology</topic><topic>Nausea - physiopathology</topic><topic>Original</topic><topic>Patient Dropouts</topic><topic>Patients</topic><topic>Peptides</topic><topic>Peptides - administration & dosage</topic><topic>Peptides - adverse effects</topic><topic>Peptides - therapeutic use</topic><topic>Retrospective Studies</topic><topic>Self Report</topic><topic>Severity of Illness Index</topic><topic>Sex Factors</topic><topic>type 2 diabetes</topic><topic>Venoms - administration & dosage</topic><topic>Venoms - adverse effects</topic><topic>Venoms - therapeutic use</topic><topic>Weight Loss - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Horowitz, Michael</creatorcontrib><creatorcontrib>Aroda, Vanita R.</creatorcontrib><creatorcontrib>Han, Jenny</creatorcontrib><creatorcontrib>Hardy, Elise</creatorcontrib><creatorcontrib>Rayner, Chris K.</creatorcontrib><collection>Wiley-Blackwell Open Access Collection</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Horowitz, Michael</au><au>Aroda, Vanita R.</au><au>Han, Jenny</au><au>Hardy, Elise</au><au>Rayner, Chris K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Upper and/or lower gastrointestinal adverse events with glucagon‐like peptide‐1 receptor agonists: Incidence and consequences</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2017-05</date><risdate>2017</risdate><volume>19</volume><issue>5</issue><spage>672</spage><epage>681</epage><pages>672-681</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><coden>DOMEF6</coden><abstract>Aims
To characterize gastrointestinal adverse events (AEs) with different glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs).
Methods
Two retrospective intention‐to‐treat analyses of 6‐month patient‐level data were conducted. Data from three studies comparing exenatide once weekly (n = 617) with exenatide twice daily (n = 606) were pooled, and one (DURATION‐6) comparing exenatide once weekly (n = 461) with liraglutide (n = 450) was analysed separately. Patient‐reported gastrointestinal AEs were classified as upper or lower, AE incidences and timing were determined, subgroups were analysed, and associations of gastrointestinal AEs with efficacy were examined.
Results
Nausea was the most common gastrointestinal AE for all treatments. Fewer exenatide once‐weekly‐treated vs exenatide twice‐daily‐ or liraglutide‐treated patients reported gastrointestinal AEs (34% vs 45% and 25% vs 41%, respectively; both
P
< .0001). Fewer exenatide once‐weekly‐treated patients reported upper plus lower events than liraglutide‐treated patients (
P
< .001); the difference between exenatide once weekly and twice daily was not significant. Within each group, more women than men reported gastrointestinal AEs. Events occurrred early and were predominantly mild. Glycated haemoglobin reductions were similar for patients with or without gastrointestinal AEs. Weight loss was greater for patients with gastrointestinal AEs with exenatide once weekly and exenatide twice daily (
P
< .05); no difference was observed in DURATION‐6.
Conclusions
Gastrointestinal AEs were less frequent with exenatide once weekly vs exenatide twice daily or liraglutide, and combined upper and lower events occurred less often. Gastrointestinal AEs were typically mild and occurred early. Gastrointestinal AEs did not affect glycaemic control but may be associated with greater weight loss.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>28058769</pmid><doi>10.1111/dom.12872</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-5527-256X</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Diabetes, obesity & metabolism, 2017-05, Vol.19 (5), p.672-681 |
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| source | MEDLINE; Wiley Online Library |
| subjects | Adverse events Agonists Antidiabetics Diabetes Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Drug Administration Schedule Exenatide Female Gastrointestinal Diseases - chemically induced Gastrointestinal Diseases - epidemiology Gastrointestinal Diseases - physiopathology gastrointestinal disorders GLP-1 receptor agonists Glucagon Glucagon-Like Peptide-1 Receptor - agonists Glucagon-Like Peptide-1 Receptor - metabolism Glycated Hemoglobin A - analysis Hemoglobin Humans Hyperglycemia - prevention & control Hypoglycemia - prevention & control Incidence Incretins - administration & dosage Incretins - adverse effects Incretins - therapeutic use Intention to Treat Analysis liraglutide Liraglutide - administration & dosage Liraglutide - adverse effects Liraglutide - therapeutic use Male Nausea - chemically induced Nausea - epidemiology Nausea - physiopathology Original Patient Dropouts Patients Peptides Peptides - administration & dosage Peptides - adverse effects Peptides - therapeutic use Retrospective Studies Self Report Severity of Illness Index Sex Factors type 2 diabetes Venoms - administration & dosage Venoms - adverse effects Venoms - therapeutic use Weight Loss - drug effects |
| title | Upper and/or lower gastrointestinal adverse events with glucagon‐like peptide‐1 receptor agonists: Incidence and consequences |
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